FDA.reportPublic FDA data

Curaplex

Primary DI
00818834026246
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-0318LTEZMM-PED
Catalog number
301-0318LTEZMM-PED
Device description
Pediatric Procedural Oxygen Mask - Medium Concentration & CO2 Monitoring (Male to Male)
Published
2019-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYGMASK, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818834026253PackageGS130Not in Commercial Distribution
00818834026246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818834026253008188340262538188340262530818834026253
00818834026246008188340262468188340262460818834026246

GMDN Terms#

Term, Definition table
TermDefinition
Capnography oxygen maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway, and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status. It includes exhaled air sampling tubing for connection to a carbon dioxide monitor (capnograph), or physiology-monitoring sedation/anaesthesia system, for the measurement of end-tidal carbon dioxide (EtCO2) in expiratory gases; it is typically used during anaesthesia/sedation or bedside monitoring. This is a single-use device.

Regulatory Flags#

DUNS number
010712461
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818834028417Curaplex301-0903301-09032020-11-30
00818834028837MiiS Horus Endoscope Display System -Video BoxEVS 7002025-08-12
00812574026481Curaplex301-P3002EA2017-02-06
00818834028608Curaplex301-12218301-122182024-03-10
00818834028615Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028622Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028639Curaplex301-12218301-122182024-03-10
00818834028646Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028684Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028448Curaplex301-PrO2LT301-PrO2LT2024-01-10
00818834028455Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2024-01-10
00818834028462Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2024-01-10
00818834028479Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2024-01-10
00818834028486Curaplex301-PrO2LTEZ301-PrO2LTEZ2024-01-10
00818834028493Curaplex301-PrO2LT-FM301-PrO2LT-FM2024-01-10
00818834028509Curaplex301-PrO2LT-0301-PrO2LT-02024-01-10
00818834028516Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2024-01-10
00812574026221Curaplex301-005-100102017-02-06
00812574025064Curaplex301-005-100102017-12-22
00818834020466Curaplex301-180U301-180U2019-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14